MisophoniaPROMISENCT06921187
Study of Auditory Perception After Progressive Exposure to Aversive Sounds in People With Misophonia
A study testing Psychoacoustic test, semi-structured interviews and Exposure to unpleasant sounds in people with Misophonia, run by Institut Pasteur at 2 sites in France.
Trial summary
The primary objective of the project is to characterise and measure the auditory perception of subjects with misophonia compared with the auditory perception of control subjects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Misophonia
- What is being tested?
- Psychoacoustic test, semi-structured interviews and Exposure to unpleasant sounds
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 2 sitesFrance
- Study dates
- Jun 2025to Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For all participants
- Obtain oral consent from the participant after receiving information about the study,
- Be 18 years or older on the day of inclusion,
- Be fluent in French (spoken and written),
- Have no known hearing loss, verified by pure tone audiometry.
- Declare that they do not have tinnitus,
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- Declare that they do not have hyperacusis, verified by measuring discomfort thresholds.
- Be affiliated to the social security or equivalent scheme.
- For participants with misophonia:
- Declare discomfort, reduced tolerance to specific sounds (mouth noises, throat clearing, breathing, etc.).
Who cannot join
- Bear the after-effects of an ear infection and/or have a history of an ENT disease that permanently affects hearing or balance (vestibular schwannoma, Ménière's disease, sudden or fluctuating deafness, congenital hypoacusis),
- Be under guardianship,
- deprived of liberty by judicial or administrative decision, or subject to legal protection.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Paul Avan contact
France2 sites
Centre de Recherche en Psychologie et Neuroscience (CRPN)
Marseille, 13003
Arnaud Norena, +33488576863, arnaud.norena@univ-amu.fr
CEntre de Recherche et d'Innovation en Audiologie Humaine
Paris, 75015
Paul Avan, +331 76 53 50 93, paul.avan@pasteur.fr
About this study
Official title: Etude de la Perception Auditive après Exposition PROgressive Aux Sons Aversifs Chez Des Personnes MISophonEs
The primary objective of the project is to characterise and measure the auditory perception of subjects with misophonia compared with the auditory perception of control subjects.
- Conditions
- Misophonia
- Being tested
- Psychoacoustic test, semi-structured interviews, Exposure to unpleasant sounds
- Medical subject headings
- misophonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoacoustic testBehavioural
Natural sounds will be presented at different decibels (dB), and the subject will be asked to rate the pleasantness/unpleasantness of the sound heard on a visual analogue scale, as well as the loudness (subjective intensity) of the sound heard.
semi-structured interviewsOther
interview, designed under the supervision of a psychologist and using the methodology of micro-phenomenological interviews the aim of these interviews is to gain access to the participants' experiences, as they describe them in the first person, during misophonic episodes
Exposure to unpleasant soundsOther
Home exposure is a practice whereby participants voluntarily subject themselves to SMs in a controlled environment.
Participants will be asked to complete two tasks: firstly, they will have to expose themselves to all 10 sounds at least twice a week; secondly, they will have to record the annoyance felt for each sound and the subjective loudness (loudness) of each SM using VAS.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Not described Receives: Behavioral: Psychoacoustic test; Other: semi-structured interviews |
| Misophonia group | Experimental | Not described Receives: Behavioral: Psychoacoustic test; Other: semi-structured interviews; Other: Exposure to unpleasant sounds |
What is being measured
The primary outcome is the main question the study is designed to answer.
score on a visual analogue scale from 0 (pleasant sound) to 10 (unpleasant sound)
sounds will be presented at different decibels and the subject will be asked to rate the pleasantness/unpleasantness of the sound on a visual analogue scale
Measured: 1 week after enrollment
score on a visual analogue scale from 0 (very low intensity) to 10 (extremely intense)
sounds will be presented at different decibels and the subject will be asked to rate the intensity of the sound on a visual analogue scale
Measured: 1 week after enrollment
Secondary outcomes (3)
Measuring the consistency of the psychoacoustic test
consistency measured by calculating Cronbach's alpha coefficient
Measured: 1 week after enrollement
the number of redundant themes in the semi-structured interviews
the interviews consist of open-ended questions covering different aspects of the experiences of misophone subjects
Measured: 1 month after enrollment
score on a visual analogue scale from 0 (very little discomfort) to 10 (extreme discomfort)
Measured: 1 month after enrollment and 2 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study startJun 2025 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MisophoniaStudies of the same condition, open and under way.
- More trials run by Institut PasteurThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- exposure to unpleasant sounds at home is the focus of this study
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institut de l'Audition
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06921187
- Sponsor's protocol ID
- 2024-058
- Other IDs
- 2024-A02048-39
- Acronym
- PROMISE
- Status last verified
- Mar 2025
- First submitted
- 18 Mar 2025
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etude de la Perception Auditive après Exposition PROgressive Aux Sons Aversifs Chez Des Personnes MISophonEs
- ClinicalTrials.gov ID
- NCT06921187
- Acronym / sponsor ID
- PROMISE / 2024-058
- Conditions
- Misophonia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Institut PasteurIndustry (pharma, biotech, devices)
- Collaborators
- Institut de l'Audition
- Study start
- Jun 2025 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 10 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the project is to characterise and measure the auditory perception of subjects with misophonia compared with the auditory perception of control subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- exposure to unpleasant sounds at home is the focus of this study
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Behavioral: Psychoacoustic test, Other: semi-structured interviews |
| Misophonia group | Experimental | Behavioral: Psychoacoustic test, Other: semi-structured interviews, Other: Exposure to unpleasant sounds |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- For all participants
- Obtain oral consent from the participant after receiving information about the study,
- Be 18 years or older on the day of inclusion,
- Be fluent in French (spoken and written),
- Have no known hearing loss, verified by pure tone audiometry.
Key exclusion criteria (3 listed)
- Bear the after-effects of an ear infection and/or have a history of an ENT disease that permanently affects hearing or balance (vestibular schwannoma, Ménière's disease, sudden or fluctuating deafness, congenital hypoacusis),
- Be under guardianship,
- deprived of liberty by judicial or administrative decision, or subject to legal protection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychoacoustic testNatural sounds will be presented at different decibels (dB), and the subject will be asked to rate the pleasantness/unpleasantness of the sound heard on a visual analogue scale, as well as the loudness (subjective intensity) of the sound heard. | Behavioural | Control group, Misophonia group |
| semi-structured interviewsinterview, designed under the supervision of a psychologist and using the methodology of micro-phenomenological interviews the aim of these interviews is to gain access to the participants' experiences, as they describe them in the first person, during misophonic episodes | Other | Control group, Misophonia group |
| Exposure to unpleasant soundsHome exposure is a practice whereby participants voluntarily subject themselves to SMs in a controlled environment. Participants will be asked to complete two tasks: firstly, they will have to expose themselves to all 10 sounds at least twice a week; secondly, they will have to record the annoyance felt for each sound and the subjective loudness (loudness) of each SM using VAS. | Other | Misophonia group |
Primary outcome
score on a visual analogue scale from 0 (pleasant sound) to 10 (unpleasant sound)
Time frame: 1 week after enrollment
sounds will be presented at different decibels and the subject will be asked to rate the pleasantness/unpleasantness of the sound on a visual analogue scale
score on a visual analogue scale from 0 (very low intensity) to 10 (extremely intense)
Time frame: 1 week after enrollment
sounds will be presented at different decibels and the subject will be asked to rate the intensity of the sound on a visual analogue scale
3 secondary outcomes
Measuring the consistency of the psychoacoustic test
Time frame: 1 week after enrollement
the number of redundant themes in the semi-structured interviews
Time frame: 1 month after enrollment
score on a visual analogue scale from 0 (very little discomfort) to 10 (extreme discomfort)
Time frame: 1 month after enrollment and 2 months after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul Avan contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoacoustic test, semi-structured interviews and Exposure to unpleasant sounds in people with Misophonia, run by Institut Pasteur at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arnaud Norena (+33488576863, arnaud.norena@univ-amu.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
score on a visual analogue scale from 0 (pleasant sound) to 10 (unpleasant sound) (time frame: 1 week after enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.